DE-SHALOM PHARMA LAB
⚠️ Moderate Risk
FEI: 3022742502 • Ilesa Osun • NIGERIA
FEI Number
3022742502
Location
Ilesa Osun
Country
NIGERIAAddress
Km 4 Iloko Ijesa Rd, , Ilesa Osun, , Nigeria
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/22/2024 | 61CCA99ANTI-ANEMIC, N.E.C. | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is DE-SHALOM PHARMA LAB's FDA import refusal history?
DE-SHALOM PHARMA LAB (FEI: 3022742502) has 1 FDA import refusal record(s) in our database, spanning from 11/22/2024 to 11/22/2024.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. DE-SHALOM PHARMA LAB's FEI number is 3022742502.
What types of violations has DE-SHALOM PHARMA LAB received?
DE-SHALOM PHARMA LAB has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about DE-SHALOM PHARMA LAB come from?
All FDA import refusal data for DE-SHALOM PHARMA LAB is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.